POSITION SUMMARY:

The incumbent is responsible for leading and overseeing day-to-day Quality Assurance (QA) operations for the LyFE manufacturing facility, including leadership for the QA team. This role has primary responsibility for drug product batch disposition and collaborates closely with the LyFE GMP Manufacturing Center teams to support technology transfers and continuous improvements of GMP processes. The incumbent will perform and oversee routine Quality Assurance activities, including but not limited to batch record review and disposition, raw material disposition, and approval of records (e.g. deviation, CAPAs, change controls, and nonconformances).  This role also supports broader Quality Operations activities to ensure compliance, operational excellence, and product quality.

KEY ROLE AND RESPONSIBILITIES:

• Responsible for supporting Quality oversight of GMP operations at the manufacturing facility and ensuring adherence to applicable GMP regulations and Lyell policies and procedures.
• Responsible for ensuring drug products are promptly dispositioned at the appropriate stages (Release for Infusion, Release for shipment etc.) to ensure on time product delivery to patient.
• Perform review and approval of executed electronic batch records, including the identification and investigation of deviations with cross functional personnel.
• Provide on the floor quality support for applicable manufacturing operations in the cleanroom facilities during operations (potentially including non-routine working hours and holidays).
• Perform routine QA activities including incoming patient apheresis receipt, drug product packaging operations, drug product disposition and audit support.
• Perform routine raw material review and disposition and approval of raw material.
• Provide quality oversight as well as review and approval of QMS records (Deviations, Change Controls, Excursions, CAPAs, Non-Conformances, Complaints).
• Maintain Quality Key Performance Indicators (KPIs) to achieve business goals.
• Represent Quality Assurance on project specific teams for clinical products. 
• Collaborate with other leaders at the site to assist in the continuous improvement, lifecycle management of GMP procedures and BLA/PLI readiness activities.

KNOWLEDGE SKILLS AND ABILITIES:

• Experience in cGMP clinical manufacturing required.
• Experience with electronic quality management systems (e.g. deviations, CAPAs, change management) required.
• Demonstrated ability to lead, mentor, and develop team members, including setting performance expectations, providing coaching, and fostering professional growth.
• Proven capability to oversee QA operations and workflows, ensuring timely execution, compliance, and alignment with organizational priorities.
• Ability to work effectively (both independently and cross-functionally) with Manufacturing, MSAT, Regulatory, Patient Operations, Supply Chain, and external partners to set goals, develop sound project plans, monitor progress, and report results.
• Excellent communication, emotional intelligence and interpersonal skills.
• Curious and proactive mindset with a continuous improvement orientation; actively seeks to understand processes, identify risks, and implement sustainable quality solutions.
• Fast learner, adaptable, and has the desire and ability to work in a fast-paced, start-up environment.
• Excellent analytical skills and scientific/technical expertise.

PREFERRED EDUCATION:

• BS with a minimum of 10 years’ experience in biochemistry, chemical engineering, bioengineering, or related scientific field; or
• MS with a minimum of 7 years’ experience in biochemistry, chemical engineering, bioengineering, or related scientific field

PREFERRED EXPERIENCE:

• Minimum of 10 years of experience in cGMP biopharmaceutical manufacturing operations including 2 years in cell therapy and/or lentiviral manufacturing operations.
• Minimum of 3 years of experience managing people in technical GMP roles.
• Minimum of 3 years in GMP Quality Assurance and/or extensive experience with quality management systems (e.g. Deviations, CAPAs, Change Controls).

PHYSICAL REQUIREMENTS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:

• Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable.
• Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe non-sterile and sterile gowns.

SHIFT WORK, WEEKEND WORK AND HOLIDAY COVERAGE:

Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, shift work, weekend work, and holiday work will occasionally be required. We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us. Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients.